# K965160: HP Orvue Intra-OP (M2510A)

- Pathway: 510(k) (Traditional)
- Applicant: Hewlett-Packard GmbH
- Decided: Sep 11, 1997 after 262 days
- Product code: BSZ (Gas-Machine, Anesthesia)
- Device class: 2
- Regulation: 21 CFR 868.5160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K870380 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922210: Hewlett-Packard Model 78730 Carevue 5000, Hewlett-Packard Co. (1993) Summary page 1.
- K922058: Models M1175A and M1176A Component Monitoring Syst, Hewlett-Packard Co. (1992) Summary page 1.
- K870380: Model 78534C Monitor/Terminal W/Options  A03, Hewlett-Packard Co. (1987) Summary page 1.

## Indications for use
The HP ORVue Intra-Op [M2510A] Intraoperative Recording System is indicated for use in healthcare facilities by healthcare professionals whenever there is a need for a anesthesia record. This product is indicated for all patients requiring a anesthesia record. The specific medical indication for use of this device is: « This device is a prescription device. o This device is not intended to contact the patient. e This device is used continuously in Operating Theatres during Anesthesia « The Recording of calculations (Fluid, Hemodynamic, Renal, Oxygenation and Ventilation) indicated for any patient who will have medication administered and which requires dose computation. « The physiological purpose is indirect. The device is intended to gather and store patient information during Anesthesia, and to document computed calculations as needed by care providers.

Source page: https://510kreport.com/device/K965160
Methodology: https://510kreport.com/methodology